As a clinical trial statistician or programmer, challenge anything in this benchmark: describe a problem in Comments, or propose a fix with the Edit button on any source file.
- Task: Is this a specification error a study team could realistically make, and should the build stop on it rather than continue?
- Inputs: Do they trigger the failure for the reason the summary gives?
- Expected failure: Is this the right error, raised at the right point, and would it tell the programmer what to fix?
The other tabs beside Comments are background for assessment, not under review.
Summary
README.mdGoal: derive SEX for each subject of a subject list from the
subject's collected answer.
Input: a subject list naming each subject, and long-form Operational Data Model (ODM) data with one row per collected item.
Variables:
SEXwould be the subject's answer to the sex question.
Each record is built from the subject list, so none of them was built from collected items, and an item has no records of its own to be read from. The request is rejected before any data is read.
How to fix
Build the records from the collected items, one per subject, and read the answer there:
input:
ODM: input/odm.csv
columns:
- name: USUBJID
derivation: ODM.SubjectKey
- name: SEX
derivation: {odm: ODM.IT.DM.SEX}
A subject list that decides which subjects appear is then a filter or a lookup against those records, not the place they are built from.
Expected failure
Editthe run is rejected; no artifact is acceptedexpected/error.yaml- phase
- validation
- condition
- invalid_odm_context
- requirement
- REQ-1277
expected/error.yaml
phase: validation
condition: invalid_odm_context
spec_paths:
- columns.SEX.derivation.odm
requirement: REQ-1277
context:
dataset: ODM
location: column
Inputs
Under review2 source filesinput/dm_raw.csv
Edit2 rows| STUDYID | USUBJID |
|---|---|
| STUDY01 | |
| STUDY01 |
input/odm.csv
Edit4 rows| StudyOID | MetaDataVersionOID | SubjectKey | StudyEventOID | StudyEventRepeatKey | FormOID | FormRepeatKey | ItemGroupOID | ItemGroupRepeatKey | ItemOID | Value |
|---|---|---|---|---|---|---|---|---|---|---|
| STUDY01 | MDV.1 | 001 | SCREENING | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.SEX | F |
| STUDY01 | MDV.1 | 001 | SCREENING | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.AGE | 34 |
| STUDY01 | MDV.1 | 002 | SCREENING | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.SEX | M |
| STUDY01 | MDV.1 | 002 | SCREENING | 1 | FO.DM | 1 | IG.DM | 1 | IT.DM.AGE | 28 |
Unexpected Output
Under reviewNo artifact is producedNo fixture files in this directory.
Comments and assessment materials
| Variable Name | Variable Label | Type | Length | Controlled Terms or Format | Origin | Core | Conversion Definition | Variable Type | Variable Order | Comments for Define |
|---|---|---|---|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | Collected | Copy value from DM_RAW.STUDYID. | SDTM | 1 | ||||
| USUBJID | Unique Subject Identifier | Char | Collected | Copy value from DM_RAW.USUBJID. | SDTM | 2 | ||||
| SEX | Sex | Char | Collected | Read collected ODM item IT.DM.SEX; no identified record yields blank. | SDTM | 3 |
| Version | Date | Author | Description | Reviewer | Sign-off |
|---|---|---|---|---|---|
| 1.3 | 2026-09-29 | yamaa docs build | Show study codelist names, external dictionaries, and ISO 8601 formats in variable rows; list the document's codelist values and metadata | ||
| 1.2 | 2026-09-29 | yamaa docs build | Classify ADaM copies from a declared input as Predecessor and recodes as Derived, and SDTM recodes of locally derived columns as Derived | ||
| 1.1 | 2026-09-29 | yamaa docs build | Resolve lookups into the donor record they select, and give every derivation shape a plain-language rule instead of its raw YAML | ||
| 1.0 | yamaa docs build | Initial generation from spec.yaml |
yamaa
Comments
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